13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Citrefix Knotless Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Punch
FDA UDI
ADLER ORTHO SPA·08053617185228·PUNCH FOR TIBIA MB GENUS PANTHEON SZ. 3-4
STICK NET
FDA 510(k)
FDA Class 2
·Dental
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
FDA 510(k)
FDA Class 2
·Cardiovascular
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 10, 2025
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Injury
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·May 17, 2016
QUANTUM MAVERICK MR BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·October 15, 2008
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PAH·July 2, 2013
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012